AFSTYLA 500 IU Powder and Solvent for Solution for Injection

What is AFSTYLA 500 IU

AFSTYLA is a recombinant, single-chain human coagulation factor VIII concentrate used for the treatment and prevention of bleeding in patients with hemophilia A (congenital factor VIII deficiency).

• Generic name: Lonoctocog alfa
• Formulation: Powder and solvent for solution for injection
• Strength: 500 IU
• Packaging: 1 kit including a powder vial, a 2.5 ml water for injection (WFI) vial, filter transfer device, administration set, and accessories

AFSTYLA is engineered to have a single-chain structure that improves stability and binding to von Willebrand factor, extending its half-life compared to standard recombinant factor VIII products.

• It is used in children and adults.
• Indicated for routine prophylaxis, on-demand treatment, and surgical bleeding management.
• Not used for von Willebrand disease or other bleeding disorders.

How to use AFSTYLA 500 IU

AFSTYLA should be administered under the supervision of a healthcare professional experienced in hemophilia treatment. It is given via intravenous (IV) injection after proper reconstitution.

• Step 1 – Preparation: Bring the powder and solvent to room temperature (not above 37°C). Avoid heating directly.
• Step 2 – Reconstitution: Use the provided filter transfer device to mix the solvent with the powder. Swirl gently until fully dissolved (typically in less than 10 minutes).
• Step 3 – Inspection: Ensure the solution is clear and colorless. Do not use if cloudy or contains particles.
• Step 4 – Injection: Use the included disposable syringe and venipuncture set to administer intravenously. Inject slowly over several minutes (maximum rate per labeling).
• Step 5 – Disposal: Discard used items safely. Follow institutional or local biohazard disposal protocols.

It is crucial to:

• Follow the prescribed dose and schedule
• Document batch numbers for traceability
• Use immediately after reconstitution

Mode of Action AFSTYLA 500 IU

AFSTYLA (Lonoctocog alfa) replaces the missing or deficient coagulation factor VIII in patients with hemophilia A. Its mode of action is rooted in the physiological clotting cascade.

• Factor VIII acts as a cofactor for factor IXa, forming a complex that activates factor X to Xa in the presence of calcium and phospholipids.
• This cascade leads to the transformation of prothrombin to thrombin and ultimately the formation of a stable fibrin clot.
• AFSTYLA’s single-chain design enhances binding to von Willebrand factor, which stabilizes it in circulation and reduces degradation.
• Its recombinant nature reduces the risk of blood-borne pathogen transmission and immunogenicity from plasma-derived products.

The improved stability and extended half-life allow for:

• Less frequent dosing (every other day or 2–3 times per week for prophylaxis)
• More consistent factor VIII activity levels
• Better adherence and quality of life for patients

AFSTYLA 500 IU Interactions AFSTYLA 500 IU

While AFSTYLA (Lonoctocog alfa) is not extensively metabolized like typical pharmaceuticals, there are still important considerations regarding potential interactions.

• Factor VIII inhibitors (neutralizing antibodies): These can develop in some patients and render AFSTYLA less effective or ineffective. Patients should be monitored regularly.
• Antifibrinolytic agents: Drugs like tranexamic acid or aminocaproic acid can be used adjunctively during dental or surgical procedures to reduce bleeding but must be monitored to avoid excessive clotting.
• Other intravenous products: AFSTYLA should not be mixed with other drugs or infusions. Always administer via a separate line or flush thoroughly before and after use.
• Immunosuppressants or immune modulators: In rare cases where inhibitors develop, immune tolerance induction (ITI) protocols may be initiated using agents that may interact or alter response to AFSTYLA.

There are no known food or herbal interactions, but patients should inform their healthcare provider of all medications and supplements being taken.

Dosage of AFSTYLA 500 IU

The dosage of AFSTYLA is individualized based on patient needs, body weight, the severity of bleeding, and factor VIII levels. It is expressed in International Units (IU).

• On-demand treatment:
  • Mild bleeding: 20–40 IU/kg
  • Moderate bleeding: 30–60 IU/kg
  • Severe bleeding: 60–80 IU/kg
• Routine prophylaxis:
  • Children & adolescents: 15–50 IU/kg 2–3 times per week
  • Adults: 20–50 IU/kg every other day or 3 times per week
• Surgical procedures:
  • Minor surgery: 30–60 IU/kg before surgery and daily until healing
  • Major surgery: 60–80 IU/kg preoperatively with maintenance doses

Important considerations:

• Monitoring of factor VIII activity may guide dosage adjustments
• Doses should be calculated using actual body weight
• Use within 3 hours after reconstitution

Possible side effects of AFSTYLA 500 IU

Like all medications, AFSTYLA can cause side effects. While most are mild and manageable, some may be serious or require immediate attention.

• Common side effects:
  • Headache
  • Injection site reactions (pain, redness, swelling)
  • Nausea or mild fever
• Less common but serious side effects:
  • Development of factor VIII inhibitors (may reduce efficacy)
  • Hypersensitivity reactions (rash, urticaria)
  • Anaphylaxis (very rare)
• Immunogenicity:
  • Inhibitor formation is more common in previously untreated patients (PUPs) than in previously treated patients (PTPs)

Patients should be educated on signs of allergic reactions and the importance of reporting any unusual symptoms promptly.

AFSTYLA 500 IU Contraindications AFSTYLA 500 IU

AFSTYLA is generally well tolerated, but its use is contraindicated in certain clinical situations.

• Known hypersensitivity: Patients with known allergy to Lonoctocog alfa, any excipients in the formulation (e.g., polysorbate 80), or hamster proteins (used in production) should not receive AFSTYLA.
• Active inhibitors: If a patient has high-titer factor VIII inhibitors, AFSTYLA may be ineffective and alternative bypassing agents should be used.
• Severe allergic or anaphylactic reactions: If a severe reaction occurs following administration, further use is contraindicated unless under close supervision.

Caution is advised in patients with:

• History of hypersensitivity to recombinant proteins
• Previous anaphylactic reactions to blood products

Storage of AFSTYLA 500 IU

Proper storage of AFSTYLA is critical to ensure its safety, sterility, and effectiveness.

• Unopened vials:
  • Store in a refrigerator at 2°C to 8°C
  • Do not freeze
  • Keep in the original box to protect from light
• Room temperature storage:
  • AFSTYLA may be stored at room temperature (not above 25°C) for a single period of up to 6 months
  • Once removed from refrigeration, do not return to refrigerator
  • Record the date it was removed to track expiration
• After reconstitution:
  • Use immediately, within 3 hours of preparation
  • Do not refrigerate after reconstitution
  • Do not use if the solution is cloudy or contains particles

Keep all medications out of the reach of children and properly dispose of unused or expired products.